BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Carotid

    PMA: P040012 · Supplement: S034 · Decision May 6, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Stent, Carotid
    Trade Name
    RX ACCULINK CAROTID STENT SYSTEM
    PMA Number
    P040012
    Supplement Number
    S034
    Device Class
    FDA Class 3
    Product Code
    NIM
    Generic Name
    Stent, carotid
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 6, 2011
    Date Received
    October 1, 2010
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    11M-0343

    Advisory Committee Statement

    APPROVAL FOR THE RX ACCULINK CAROTID STENT SYSTEM. THE DEVICE IS INDICATED FOR HIGH SURGICAL RISK AND STANDARD SURGICAL RISK PATIENTS AS FOLLOWS: HIGH SURGICAL RISK -THE RX ACCULINK CAROTID STENT SYSTEM, USED IN CONJUNCTION WITH ABBOTT VASCULAR'S ACCUNET OR EMBOSHIELD FAMILY OF EMBOLIC PROTECTION SYSTEMS (EPS), IS INDICATED FOR THE TREATMENT OF REVASCULARIZATION AND MEET THE CRITERIA OUTLINED BELOW: 1) PATIENTS WITH NEUROLOGICAL SYMPTOMS AND >= 50% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRASOUND OR ANGIOGRAM OR PATIENTS WITHOUT NEUROLOGICAL SYMPTOMS AND >= 80% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRASOUND OR ANGIOGRAM; AND PATIENTS MUST HAVE A REFERENCE VESSEL DIAMETER WITHIN THE RANGE OF 4.0 MM AND 9.0 MM AT THE TARGET LESION. STANDARD SURGICAL RISK - THE RX ACCULINK CAROTID STENT SYSTEM, USED IN CONJUNCTION WITH THE ACCUNET EMBOLIC PROTECTION SYSTEM (EPS), IS INDICATED FOR THE TREATMENT OF PATIENTS AT STANDARD RISK FOR ADVERSE EVENTS FROM CARTOID ENDARTERECTOMY WHO REQUIRE CAROTID REVASCULARIZATION AND MEET THE CRITERIA OUTLINED BELOW: 1) PATIENTS WITH NEUROLOGICAL SYMPTOMS AND >= 70% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRASOUND OR >= 50% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ANGIOGRAM OR PATIENTS WITHOUT NEUROLOGICAL SYMPTOMS AND >= 70% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRASOUND OR >= 60% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ANGIOGRAM; AND PATIENTS MUST HAVE A REFERENCE VESSEL DIAMETER WITHIN THE RANGE OF 4.0 MM AND 9.0 MM AT THE TARGET LESION.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NIM Stent, Carotid